Kornimate/medical-research-clean huggingface dataset:
study of adjunctive ganaxolone treatment in female children with protocadherin 19 (pcdh19)-related epilepsy (violet study)

Conditions: PCDH19-Related Epilepsy

Summary: a clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in female children and young adults with genetically confirmed pcdh19 gene mutation.

the violet study is a global, double-blind, placebo-controlled, phase 2 clinical trial that plans to enroll approximately 25 female patients between the ages of 1 and 17 with a confirmed disease-related pcdh19 gene variant. patients will undergo a baseline period before being randomized to receive, in addition to their existing anti-seizure treatment, either ganaxolone or placebo for 17 weeks. following the treatment period, all patients that meet certain eligibility requirements will have the opportunity to receive ganaxolone in the open label phase of the study. the study's primary efficacy endpoint is percent reduction in seizures. secondary outcome measures will include non-seizure-related endpoints to capture certain behavioral and sleep disturbances that have been seen in previous clinical studies with ganaxolone.

Eligibility criteria:
inclusion criteria: * molecular confirmation of a pathogenic or likely pathogenic pcdh19 variant * failure to control seizures despite 2 or more anti-seizure medications * 12 seizures over a 12-week period of primary seizure types prior to screening * on a stable regimen of concomitant aeds, ketogenic diets, and modified atkins diet should be unchanged for 3 months prior to screening) exclusion criteria: * previous exposure to ganaxolone * \> 8 consecutive weeks of seizure freedom during the 12 weeks prior to screening * concurrent use of strong inducers or inhibitors of cyp3a4/5/7 is not permitted * use of tetrahydrocannabinol (thc) or non-approved cannabidiol (cbd) is prohibited during the double-blind phase * exposure to any other investigational drug within 30 days or fewer than 5 half-lives prior to screening

Keywords: refractory seizures epilepsy in children seizure disorder
developing and testing interventions to address conscientious objection to abortion care in mexico and south africa

Conditions: Abortion, Induced; Abortion, Incomplete

Summary: the primary purpose of this research is to develop strategies and interventions to mitigate the impact of conscientious objection on women's access to safe abortion care in mexico and south africa using a user-centered design approach and test the feasibility and effectiveness of these interventions.

conscientious objection (co) is emerging as a growing barrier to abortion care, and evidence suggests that it is being incorrectly used as a justification for public sector medical providers and institutions to exempt themselves from their duties to provide essential reproductive health services for women. given this, it is essential to better understand and address this misuse of co and find ways to improve women's access to safe abortion services to prevent them from using unsafe methods which risk their health and lives. this study will conduct formative research to more fully understand the problem of co in mexico and south africa and use these findings to develop interventions and strategies to mitigate the impact of co on women's access to safe abortion care using a user-centered design approach. rapid randomized controlled trials will then be used to assess effectiveness of the interventions. the specific aims of this study are: 1. improve our understanding of co and its impact on access and quality of abortion care from providers' and facility mangers' perspectives in mexico, and south africa. 2. develop strategies and interventions to mitigate the impact of co on women's access to safe abortion care. using the data collected, a multi-disciplinary innovation team will develop strategies and interventions to respond to the challenges posed by co using a user-centered design approach. 3. rapid-test intervention prototypes. we will test selected strategies (prototypes) in mexico, and south africa with assessments to determine successes, and the feasibility of scaling up these approaches.

Eligibility criteria:
south africa inclusion criteria: * all staff currently working in selected health facilities * able to provide informed consent exclusion criteria: * unable to provide informed consent mexico inclusion criteria: * doctors/anyone eligible to be an abortion provider working in selected health facilities * able to provide informed consent exclusion criteria: * unable to provide informed consent
develop and implement asthma controlling strategies (1)

Conditions: Asthma; Lung Diseases

Summary: to develop and implement asthma controlling strategies for inner city and high risk populations.

background: asthma is a serious chronic disease affecting about 12 million americans; about 3 million are children. the study was part of an initiative, "developing and implementing at the state and local level educational strategies and interventions for controlling asthma in inner city and high risk populations", released in february 1993 by the national asthma education program of the office of prevention, education and control.

Eligibility criteria:
no eligibility criteria
comparison of safety and efficacy of the combination product qva149a against the concurrent administration of the individual components, qab149 and nva237, in patients with chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the study assessed the safety and efficacy of the fixed combination product qva149 versus the component products qab149 and nva237, administered concurrently, in patients that have moderate to severe chronic obstructive pulmonary disease (copd).

the study assessed the safety and efficacy of the fixed combination product qva149 versus the component products qab149 and nva237, administered concurrently, in patients that have moderate to severe chronic obstructive pulmonary disease (copd).

Eligibility criteria:
inclusion criteria: * male or female adults aged ≥ 40 yrs * smoking history of at least 10 pack years * diagnosis of copd (moderate to severe as classified by the global initiative for chronic obstructive lung disease (gold) guidelines, 2010) * post-bronchodilator fev1 \< 80% and ≥ 30% of the predicted normal value and post-bronchodilator fev1/fvc (forced vital capacity) \< 70% exclusion criteria: * patients who have had a respiratory tract infection within 4 weeks prior to visit 1 * patients with concomitant pulmonary disease * patients with a history of asthma * any patient with lung cancer or a history of lung cancer * patients with a history of certain cardiovascular co-morbid conditions * patients with a known history and diagnosis of alpha-1 antitrypsin deficiency * patients in the active phase of a supervised pulmonary rehabilitation program * patients contraindicated for inhaled anticholinergic agents and β2 agonists other protocol-defined inclusion/exclusion criteria may apply

Keywords: chronic obstructive pulmonary disease copd qva149 qab149 nva237 indacaterol glycopyrronium bromide
peritoneal carcinomatosis extent evaluation: radiologic, laparoscopic and pathologic.

Conditions: Peritoneal Carcinomatosis

Summary: pathologically proved ovarian cancer patients that underwent contrast enhanced abdomino-pelvic ct and diagnostic laparoscopy before cytoreductive surgery (crs) will be included in the study. calculation of pci (peritoneal cancer index) using sugarbaker's method, peritoneal carcinomatosis extent will be categorized into low, moderate and large. agreement in general and in each category between ct, laparoscopy, surgery and pathology will be assessed using kappa agreement.

we will search medical records of primary ovarian cancer patients underwent ct abdomen, laparoscopy followed by cytoreductive surgery to calculate peritoneal carcinomatosis extent by each modality. regional pci was calculated in each of the 13 anatomical abdominopelvic regions, then total pci by summation of the lesion size score, it ranged from 0 to 39. categorization of peritoneal carcinomatosis was classified into 3 categories low if pci \ 20.

Eligibility criteria:
inclusion criteria:pathologically proved ovarian cancer patients underwent contrast enhanced abdominopelvic ct and diagnostic laparoscopy before cytoreductive surgery - exclusion criteria:recurrent ovarian cancer -

Keywords: ovarian neoplasms, laparoscopy, cytoreduction surgical procedures.
real-time monitoring of kidney grafts on hypothermic machine perfusion

Conditions: Transplant;Failure,Kidney

Summary: a significant number of deceased donor kidneys donated for transplantation are not used and are thrown away due to lack of ways of checking their condition and function before the operation. this significantly reduces the number of potentially life saving transplants. the researchers wish to run a small pilot study to see if it is possible to improve the way transplant kidneys are assessed before transplantation by measuring how well they filter the blood, and how good their metabolism is. the researchers believe this new method will help transplant surgeons make better decisions about which kidneys to use. this pilot study will look at 10 kidneys obtained from older deceased donors. these kidneys are most at risk of being thrown away because of the condition of the donor they came from. at the hospital, these kidneys are usually put onto a machine which pumps cold preservation solution through them for a couple of hours. this time lets the transplant surgeons see how well or poorly the kidney responds to the flowing fluid. in this study the research team will do exactly the same, but also insert a small probe less than a millimetre in diameter into the kidney and the vein (draining blood pipe) and urine output to monitor a number of chemicals made by the kidney. the researchers believe that the changing levels of these chemicals will give the surgeons much more information than they have now. this probe is removed when the kidney is transplanted. combining these levels with news of how well the patients recover after surgery will allow the research team to design a much larger study to get the right level of information to change the way surgeons choose kidneys and help more transplants happen in the future.


Eligibility criteria:
inclusion criteria: * all organs to be used in the study must be intended for transplantation and not already rejected/discarded. * all organs must be sourced from deceased donors through nhsbt in the normal course of clinical activity. * kidneys must come from marginal or 'imperfect' donors according to current clinical criteria. this typically indicates an age of 60 and over, or 50 and over with one or more premorbid conditions, including renal impairment, cerebrovascular disease, and hypertension. exclusion criteria: * organs from living donors are excluded. * organs from young healthy donors are excluded. * organs will be excluded if on the assessment of the clinical team they are not suitable for hypothermic machine perfusion. this indicates organs that have arrived with visible defects, or fall well outside the team's standard criteria for clinical acceptability (excessive time in transit, excessive warm ischaemia time, excessive cold ischaemia time, very poor pre-morbid donor condition).

Keywords: creatinine microdialysis
bone marrow versus adipose autologous mesenchymal stem cells for the treatment of knee osteoarthritis

Conditions: Osteo Arthritis Knee

Summary: mesenchymal stem cells (msc) are stromal cells that have the ability to self-renew and also exhibit multilineage differentiation. mscs can be isolated from a variety of tissues, such as umbilical cord, bone marrow, and adipose tissue. the multipotent properties of mscs make them a promising option for the treatment of osteoarthritis (oa). bone marrow mesenchymal stem cells (bm-msc) and adipose derived mesenchymal stem cells (ad-msc) have been used separately to treat oa. the aim of the present study will be to compare in a randomized non blind controlled clinical trial 3 types of intra-articular injections containing msc populations obtained from two clinically relevant sources: bm-msc, ad-msc and a combination of both bm-msc and ad-msc.

the aim of the present study will be to compare 3 types of intra-articular injections of msc populations obtained from two clinically relevant sources: injections containing bm-msc or ad-msc or a combination of both bm-msc,and ad-msc in a randomized non blind clinical trial. to assess the efficacy and safety of 3 kind of msc injections in relation to pain, function and quality of life in patients with knee oa. a total of 54 patients with the diagnosis of knee oa grade ii and iii will be recruited to receive a single intra-articular injection of msc: group 1 (n 18 patients) will receive bm-msc, group 3 (n 18 patients) will receive ad-msc. group 3 (18 patients) will receive a combination of bm-msc and ad-msc. a randomized non blind clinical trial with active control. for this purpose, the random number generator is 54, found on the random.org ® website (available at https://www.random.org/integers/)

Eligibility criteria:
inclusion criteria: * patients aged 18 to 70 years, with grade ii and iii knee oa, according to the ahlbäck classification will be included. * minimal vas pain score of 4. * chronic knee pain of mechanical origin. * all patients who sign a specially prepared informed consent for this clinical trial. exclusion criteria: * varus or valgus knee mal alignment superior to 10°. * oa grade iv according ahlbäck classification. * bone marrow cancer like lymphoma. * severe anemia. * active infections. * pregnant patients. * inmune diseases such as rheumatoid arthritis, gout or pseudogout arthritis, psoriasis. * bone diseases such as kahler and paget. * corticoesteroid and hyaluronic injections within the last 3 months. * knee surgery in the last 6 months.

Keywords: mesenchymal stem cell
a long term follow up administration study of l059 (levetiracetam) in epilepsy patients with partial onset seizures

Conditions: Epilepsies; Partial

Summary: this study is planned to evaluate the safety and efficacy of l059 (levetiracetam) in long-term administration in patients who completed n01020 \[nct00160165\] or n01221 \[nct00280696\].


Eligibility criteria:
inclusion criteria: * patients who participated in study n01221 \[nct00280696\] and completed the evaluation period and transition period or patients who participated in study n01020 \[nct00160615\] exclusion criteria: * female patients during pregnancy, delivery and lactation, or suspected of pregnancy

Keywords: epilepsies partial keppra levetiracetam
nasal irrigation with chinese herbal medicine as an adjunctive treatment in allergic rhinitis

Conditions: Rhinitis, Allergic; Nasal Lavage; Medicine, Chinese Traditional

Summary: in allergic rhinitis patients with severe symptoms, control of severe allergic reactions is limited with saline nasal irrigation. therefore, there have been several attempts to use saline nasal irrigation in combination with other treatments to treat allergic rhinitis. this study tries to explore the effect of nasal irrigation with chinese herbal medicines on allergic rhinitis.

in this study, patients with allergic rhinitis over 20 years old were collected from the clinics of otolaryngology and traditional chinese medicine clinics. the subjects were randomly divided into two groups. they used the devices of neimed sinus rinse to irrigate the nose with 240 cc of chinese herbal medicine solution or placebo each morning and evening for 2 months. subjects in both groups filled questionnaires, and received acoustic rhinometry, rhinomanometry, and eustachian tube function tests before and after nasal irrigation. this study tries to explore the effect of nasal irrigation with chinese herbal medicines on allergic rhinitis.

Eligibility criteria:
inclusion criteria: * allergic rhinitis patients diagnosed based on the history and allergen test exclusion criteria: * those younger than 20 years old, immunocompromised patients pregnant women or breastfeeding women those with a history of allergy to traditional chinese medicine those with liver and kidney insufficiency those who cannot cooperate with nasal irrigation

Keywords: rhinitis, allergic nasal lavage medicine, chinese traditional
central venous pressure monitoring and prognosis of high-risk operating patients

Conditions: Central Venous Pressure

Summary: while central venous pressure measurement is used to guide fluid management in high risk surgical patients during perioperative period, the relationship between the value of central venous pressure and organ dysfunction and prognosis of high-risk operating patients is unknow. in this study, we conducted a retrospective study of the relationship between the initial levels of cvp with organ dysfunction, the severity of illness, the length of icu stay, and prognosis of critically ill patients.

although less than 15% of high-risk patients (elderly or with limited cardiopulmonary reserves) undergo surgery, these patients account for 80% of hospital deaths. the requirements for hemodynamic monitoring to critical patients during perioperative period reach are of maximal importance, for two major reasons: (i) absolute or relative volume deficiency often occurs in postoperative patients due to preoperative fasting, intraoperative bleeding and non-dominant fluid loss caused by vasodilation and fluid redistribution caused by anesthesia; (ii) insufficient fluid replacement may lead to increased postoperative organ complications and poor wound healing. adequate and goal-oriented hemodynamic monitoring combined with early and appropriate treatment can improve the prognosis of high-risk surgical patients. central venous pressure is a localized parameter of the superior vena cava or the right atrium and is closely related to the right ventricular end-diastolic pressure. with volume overload, cvp levels may be abnormally elevated. maintaining central venous pressure as low as possible is conducive to the recovery of internal organs during haemodynamic treatment, especially for the kidney, intestine, and brain, etc. however, elevated central venous pressure (cvp) occurs frequently in critical care settings, including postoperative critical patients. in this study, we conducted a retrospective study of the relationship between the initial levels of cvp with organ dysfunction, the severity of illness, the length of icu stay, and prognosis of critically ill patients.

Eligibility criteria:
inclusion criteria: * age ≥18 years.⑵ all patients undergoing surgery and admitted to our intensive care unit (icu) directly after surgery were enrolled into the respective study.⑶ they stayed in the icu more than 48 hours with central venous pressure monitored for more than 48 hours. exclusion criteria: * patients who were in pregnancy. ⑵older than 80 years. ⑶underwent cardiac surgery or had chronic kidney disease.

Keywords: perioperative central venous pressure fluid management acute renal injury
early surgery versus conventional treatment in very severe aortic stenosis

Conditions: Aortic Stenosis

Summary: the optimal timing of surgical intervention remains controversial in asymptomatic patients with very severe aortic stenosis. the investigators therefore try to compare long-term clinical outcomes of early surgery with those of conventional treatment strategy in a prospective randomized trial.

management of asymptomatic patients with severe aortic stenosis (as) remains controversial, and the combined risks of aortic valve surgery and late complications of aortic valve prosthesis need to be balanced against the possibility of preventing sudden death and lowering cardiac mortality. considering that sudden cardiac death occurs at a rate of approximately 1% per year and that the average postoperative mortality of isolated av replacement is 3.0-4.0%, the 2007 european society of cardiology guidelines do not recommend aortic valve surgery for asymptomatic patients with severe as and the 2006 american college of cardiology/american heart association guidelines recommend surgery as a class iib indication only in patients with extremely severe as and who are at low operative risk. clinical outcomes vary widely according to the severity of stenosis in asymptomatic as, and asymptomatic patients with very severe as are often referred for aortic valve replacement in clinical practice despite the lack of data supporting early surgery. rosenhek et al recently reported a worse prognosis with a higher event rate and a risk of rapid deterioration in very severe as, and the investigators also recently reported that compared with the conventional treatment strategy, early surgery in patients with very severe as is associated with an improved long-term survival in a prospective, observational study. however, there have been no prospective,randomized studies comparing early surgery with a watchful waiting strategy in very severe as. we sought to compare long-term clinical outcomes of early surgery with those of conventional management based on current guidelines.

Eligibility criteria:
inclusion criteria: * asymptomatic patients with very severe aortic stenosis who are potential candidates for early surgery. very severe aortic stenosis are defined as a critical stenosis in the av area ≤ 0.75 square centimeter fulfilling one of the following criteria; a peak aortic velocity ≥ 4.5 m/sec or a mean transaortic pressure gradient ≥ 50 mmhg on doppler echocardiography. according to the revised 2014 aha/acc valvular heart disease guideline that recommends exercise testing to confirm the absence of symptoms in asymptomatic patients with severe as (class iia), eligible patients with a positive exercise test will be excluded from the entry after may, 2014. exclusion criteria: * exertional dyspnea * angina * syncope * left ventricular ejection fraction \< 50% * significant aortic regurgitation * significant mitral valve disease * pregnancy * age \ 80 years * coexisting malignancies * positive exercise test

Keywords: aortic stenosis surgery, survival